JUXTAPID Capsules Approved In Mexico For Homozygous Familial Hypercholesterol

(RTTNews) - Aegerion Pharmaceuticals Inc. (AEGR) said that the Mexican Federal Commission for the Protection against Sanitary Risk or COFEPRIS has approved JUXTAPID as an adjunct treatment to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol or LDL-C, total cholesterol or TC, apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with homozygous familial hypercholesterolemia or HoFH. In the approval of JUXTAPID, COFEPRIS gave JUXTAPID Recognition as an Orphan Drug.

HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. Often, HoFH patients develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.

Owing to the risk of liver toxicity, JUXTAPID is subject to a risk management plan that has been approved by COFEPRIS. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.